News

Moderna and Merck reported that a combination therapy involving pembrolizumab and an mRNA demonstrated a 44% reduction in recurrence or death in cancer patients compared to non-combination treatments.

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Integrated systems combine functions.

Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.

The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

The acquisition of Cell Systems will bolster AnaBios’ portfolio of human tissue and cells for use in drug discovery.

The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

If approved, Johnson & Johnson would pay $8.9 billion to resolve all current and future claims in its ongoing talc litigation.

FDA aims to address mounting criticisms of its accelerated approval pathway.

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.

Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.

Roche and Lilly will collaborate on the development of Roche Diagnostics’ Elecsys Amyloid Plasma Panel.

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

PharmaBlock has opened a new R&D facility in Pennsylvania, expanding its capacity to deliver GMP projects.

Ingredion has completed two strategic investments in India with Amishi Drugs & Chemicals and Mannitab Pharma Specialties.

Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.